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NCT02672111 · ClinicalTrials.gov registry record · Phase 3

Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder

A Phase 3 study of Opioid Use Disorder, sponsored by Braeburn Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
228
Enrollment target
20
Study locations

NCT02672111 is a Phase 3 study of Opioid Use Disorder that has completed, run by Braeburn Pharmaceuticals. The registered enrollment target is 228 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT02672111, a Phase 3 study of Opioid Use Disorder, has completed, sponsored by Braeburn Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
228 participants
Enrollment target
20
Study locations

Study Summary

Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.

Conditions Studied

Interventions

  • DRUG CAM2038 q1w or q4w exposure to SL BPN/NX
  • DRUG CAM2038 q1w or q4w new to BPN treatment

Study Locations (20)

Other

  • Newcastle Community Health Services - Newcastle
  • Drug & Alcohol Services SA Drug and Alcohol Services - Norwood
  • Royal Prince Alfred Hospital - Sydney
  • South Eastern Sydney Local Health District (SESLHD) - Sydney
  • Center for Misbrugsbehandling - Aarhus
  • Behandlingscenter Odense - Odense
  • Gemeinschaftspraxis Schnaitmann/Schaffert Salzstrasse - Heilbronn
  • Studikum - Zentrum fur Klinische Studien im Praxiszentrum Friedrichsplatz - Kassel
  • Klinik fur Abhangiges Verhalten und Suchtmedizin Zentralinstitut - Mannheim
  • Psychosoziale Begleitung - Praxis Boniakowski - Regensburg

Alabama

  • Parkway Medical Center - Birmingham
  • Haleyville Clinical Research LLC - Haleyville
  • Boyett Health Services Inc - Hamilton

Florida

  • Dr Vijapura and Associates - Jacksonville
  • TRY Research - Maitland

New Jersey

  • Wellness and Research Center - Belvidere
  • Comprehensive Clinical Research - Berlin

Massachusetts

  • Stanley Street Treatment and Resources Inc - Fall River

New York

  • STARS/Columbia University - New York

Pennsylvania

  • Frost Medical Group, LLC - Conshohocken

Trial Details

FieldValue
Enrollment Target 228 participants
Start Date 2015-11
Est. Completion 2017-05
Phase Phase 3

Sponsor

Braeburn Pharmaceuticals

8 total trials

What the Registry Record Tells You About NCT02672111

The ClinicalTrials.gov registry entry for NCT02672111 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 228 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower). The listed sponsor is Braeburn Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which CAM2038 q1w or q4w exposure to SL BPN/NX is the first listed.

NCT02672111 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Alabama, Florida.

Frequently Asked Questions

What is clinical trial NCT02672111 about?

NCT02672111 is a clinical study titled "Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder". Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.

What is the current status of trial NCT02672111?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2015-11. Estimated completion is 2017-05.

What conditions does trial NCT02672111 study?

This clinical trial studies the following conditions: Opioid Use Disorder.

What interventions are being tested in trial NCT02672111?

The interventions under investigation include: CAM2038 q1w or q4w exposure to SL BPN/NX (DRUG), CAM2038 q1w or q4w new to BPN treatment (DRUG).

Who is sponsoring clinical trial NCT02672111?

This trial is sponsored by Braeburn Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02672111 being conducted?

This trial has 20 study locations across Alabama, Florida, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.